Palisade Bio Inc - PALI STOCK NEWS

Palisade Bio announced preclinical results for PALI-2108, a novel local PDE4 inhibitor prodrug, showing promising effects in treating fibrostenotic Crohn's disease. Studies using the DSS colitis mouse model demonstrated that PALI-2108 modulated 187 genes involved in four main fibrotic pathways of IBD, with dose-dependent effects. The drug is designed for local activation in the ileum and colon, potentially offering enhanced safety compared to traditional systemic PDE4 inhibitors. The company is currently conducting a Phase 1 study with topline data expected in first half of 2025.

Palisade Bio (Nasdaq: PALI) announced its participation in the 8th Annual Antifibrotic Drug Development Summit in Boston, MA, from November 19-21, 2024. Chief Medical Officer Mitch Jones, MD, PhD, will present on fibrostenotic Crohn's Disease and local PDE4 inhibitor prodrug development on November 21 at 2:30 PM ET.

The presentation, titled 'Detailing Characteristics of Fibrostenotic Crohn's Disease Biology & the Potential of a Local PDE4 Inhibitor Prodrug to Minimize Off-Target Effects & Maximize Efficacy,' will be part of the session examining latest research in antifibrotic development. The AFDD Summit is a key forum bringing together experts in antifibrotic drug development.

Palisade Bio (Nasdaq: PALI) reported Q3 2024 financial results and key developments for PALI-2108, its lead program for treating moderate-to-severe Ulcerative Colitis (UC). The company has commenced enrollment and dosing in its Phase 1 clinical study. Notable achievements include presenting translational studies data at ACG's 2024 Annual Scientific Meeting, completing refined patient selection strategies with Strand Life Sciences, conducting a microbiome study confirming bacterial enzymes for local bioactivation, expanding intellectual property in Europe, and completing the first GMP batch of PALI-2108 drug substance.

Palisade Bio (NASDAQ: PALI) has initiated its Phase 1 clinical study of PALI-2108, dosing its first subject. The study evaluates an orally administered PDE4 inhibitor prodrug for treating moderate-to-severe Ulcerative Colitis (UC). The single-center, double-blind, placebo-controlled study will assess safety, tolerability, pharmacokinetics, and pharmacodynamics in both healthy volunteers and UC patients. The study includes single ascending dose (SAD) cohorts, food effect evaluation, multiple ascending dose (MAD) cohorts, and a UC patient cohort. Topline data is expected in first half of 2025.

Palisade Bio (NASDAQ: PALI) has presented positive data from two ex vivo translational studies of PALI-2108, their colon-specific PDE4 inhibitor prodrug for ulcerative colitis treatment. The studies demonstrated successful bioactivation in stool samples and significant TNFα inhibition in whole blood. PALI-2108 achieved a 90.1% conversion rate at 24 hours and showed 20-fold higher potency compared to apremilast. The drug's targeted activation in the colon aims to minimize systemic exposure and side effects. The company plans to initiate Phase 1 clinical trials before year-end, including studies with healthy volunteers and UC patients.

Palisade Bio (Nasdaq: PALI) has received a No Objection Letter from Health Canada for its Phase 1 clinical study of PALI-2108, an oral PDE4 inhibitor prodrug for treating Ulcerative Colitis (UC). The study will evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers and UC patients. The trial design includes Single Ascending Dose (SAD), Multiple Ascending Dose (MAD), and food effects (FE) cohorts, with approximately 90 patients planned for enrollment.

The primary objective is to assess safety and tolerability, with secondary objectives focusing on pharmacokinetics. Exploratory objectives include examining PDE4-related biomarkers and UC-specific markers. Palisade Bio aims to commence site initiation and enrollment before year-end. The company believes PALI-2108 could be the first approved PDE4 inhibitor for UC, addressing a significant medical need in a market expected to reach nearly $10 billion by 2028.

Palisade Bio, Inc. (Nasdaq: PALI) has announced its participation in the 2024 Maxim Healthcare Virtual Summit, presented by Maxim Group The company's CEO, J.D. Finley, and CMO, Dr. Mitch Jones, will engage in a fireside chat on Tuesday, October 15th at 4:30 PM ET.

Palisade Bio is a biopharmaceutical company dedicated to developing novel therapeutics for patients with autoimmune, inflammatory, and fibrotic diseases. The summit will feature presentations and interactive discussions with CEOs and key management from various healthcare sectors, including biotechnology, diagnostics, medical devices, and healthcare information technology.

Interested parties can attend the virtual event by signing up for M-Vest membership. The summit promises to offer timely and engaging industry panels alongside company presentations.

Palisade Bio (Nasdaq: PALI) has made significant progress towards launching its Phase 1 human clinical study for PALI-2108, a locally activated PDE4 inhibitor prodrug for treating ulcerative colitis (UC). The company has:

1. Completed nonclinical safety and toxicity studies
2. Finalized Phase 1 clinical trial design
3. Established Maximum Recommended Starting Dose
4. Completed pre-Clinical Trial Application (CTA) meeting with Health Canada
5. Submitted the CTA for the Phase 1 study

The Phase 1 study will be a single-center, double-blind, placebo-controlled study focusing on safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers and UC patients. Palisade Bio plans to enroll approximately 90 patients across various cohorts and remains on track to initiate the study before year-end.

Palisade Bio (Nasdaq: PALI) has launched a new corporate branding and website, reaffirming its commitment to developing next-generation precision therapies for autoimmune, inflammatory, and fibrotic diseases. The company's lead program, PALI-2108, targets moderate-to-severe ulcerative colitis and is advancing towards a Phase 1 clinical study before year-end. Palisade Bio plans to use advanced machine learning to identify patients with elevated PDE4 activity, potentially enhancing treatment efficacy. The company is also developing PALI-1908 for fibro stenotic Crohn's Disease. CEO J.D. Finley expressed confidence in the company's progress and upcoming milestones, emphasizing the potential to address significant unmet medical needs in established commercial markets.